CompletedNot Applicable

Physiological Effects of Stevia Consumption in Humans

United Kingdom30 participantsStarted 2019-02-01

Plain-language summary

This study will evaluate whether long-term consumption of the low calorie sweetener stevia affects glucose tolerance in healthy participants. With regard to this aim, we will recruit 2 study groups, the stevia group where participants will be required to add stevia drops twice daily in their habitual drinks and the control group where participants will be asked not to change anything in their diet and lifestyle.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-40 years * BMI 18.5-25 kg/m2 * No or low NNS consumers (up to 1 can of diet soda per week or 1 sachet of NNS per week) * DEBQ for restraint eating ≤ 3 * Healthy - general good health * Not taking medications that affect metabolism or appetite (i.e. thiazide diuretics, glucocorticoids or beta blockers) * Stable weight, ≤ 5 kg last 12 months * Fasting blood glucose ≤6.0 mmol/L * Willing to comply with the study protocol * No self-reported food allergy or intolerance to foods supplied during the study * The participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * The participant is able to read, comprehend and record information written in English. * A signed and dated written informed consent is obtained from the participant. Exclusion Criteria: * Age under 18 years or over 40 years old. * BMI \>25 kg/m2 and \<18.5kg/m2 * Participants who are not willing to comply with study procedures (including expression of dislike for NNS) * Habitual NNS consumers, \>1 can of diet beverage or \>1 sachet of low calorie sweeteners per week. * Fasting blood glucose measured \> 6 mmol/L * Subjects who are currently dieting and having ceased a diet in \< 4 weeks * DEBQ score for restraint eating \> 3 * Subjects who follow special diets for weight maintenance, such as Atkins Diet, Weight Watchers, gluten-free diet, The Zone diet, Vegetarian Diet, Raw Food Diet etc. * Ve…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Glucose response to an oral glucose tolerance test (OGTT) measured as incremental area under the curve (iAUC)

Timeframe: Week 0 and week 12

Trial details

NCT IDNCT03993418

SponsorUniversity of Manchester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-10

View on ClinicalTrials.gov More Glucose Intolerance trials